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Completed

NCT Number: NCT05373992

Concussion Screen Use Recovery Time

A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Study hypothesis 1 - There will be significant differences between the treatment and the control arms' mean recovery time (days). Study hypothesis 2 - The ST-restricted & exercise treatment arm will have a significantly shorter mean recovery time (days) compared with the other treatment arms and control arm.

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Key information

Conditions

Sport-related Concussion Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Health - Andrews Institute

Plano, Texas, 75024, United States

About this study

The investigators will randomize a sports related concussion (SRC) treatment protocol (n=313) of Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) pediatric SRC patients (aged 12-17 years) to one of four treatment groups:1. Screen Time (ST) restricted group, 2.Exercise group, 3.ST restricted & exercise group, and Control [stretching only]) group. The treatments will occur for the first 72-hours following the first clinic appointment. The investigators will monitor treatment adherence and 24-hour movement behaviors over a 72-hour period using the ActiGraph GT9X Link and heart rate monitor; a state-of-the-art research grade wearable device that our research team has expertise in administering and analyzing in field-based studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects
  • Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC
  • Patients who suffered a sport-related concussion within 72-hours of first clinic visit

Exclusion criteria

  • Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit
  • Is not diagnosed with a SRC
  • Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion
  • Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery
  • Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery
  • Has an increased cardiac event risk according to the American College of Sports Medicine criteria
  • Has a symptom severity score of less than 5 points on the post-concussion symptom scale during the initial clinical examination
  • Has an ability to exercise to exhaustion without symptom provocation during the initial clinical examination
  • Has limited English language proficiency

Treatment and study plan

Screen Time Restriction (ST-Restricted)

Behavioral

Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. Following the first 72-hours of restricted screen-time, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Aerobic Exercise (AE)

Behavioral

Engage in 30-minutes of aerobic exercise daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Screen-time restricted plus aerobic exercise (STR+AE)

Behavioral

Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) while concurrently engaging in daily aerobic exercise in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed STR+AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Stretching Only

Behavioral

Participants will be instructed to follow a prescribed stretching program for the first 72-hours following the initial clinic visit. Following the first 72-hours of prescribed stretching, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Primary outcomes

  1. Recovery Time

    Time frame: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities

    Primary outcome is recovery time (days) as measured as the number of days between the date of injury and day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities, which must occur for at least three consecutive days.

Secondary outcomes

  1. Protracted recovery

    Time frame: Greater than 30-days

    Secondary outcome is protracted recovery. A positive classification for protracted recovery is defined as a recovery time, as specified previously, greater than 30-days.

Sponsors and collaborators

Lead sponsor

Children's Health

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Official study title

Effect of Exercise and Restrictions to Screen-time on Sport-related Concussion Recovery Time Among Adolescents

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 13, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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